UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023302
Receipt No. R000026751
Scientific Title Studies on effects of medium-chain triglyceride (MCT) on physical function in elderly subjects.
Date of disclosure of the study information 2016/08/01
Last modified on 2019/07/27 (Ver. 11)

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Basic information
Public title Studies on effects of medium-chain triglyceride (MCT) on physical function in elderly subjects.
Acronym Effects of medium-chain triglyceride on muscle and cognitive function.
Scientific Title Studies on effects of medium-chain triglyceride (MCT) on physical function in elderly subjects.
Scientific Title:Acronym Effects of medium-chain triglyceride on muscle and cognitive function.
Region
Japan

Condition
Condition Frail elderly subjects
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether medium-chain triglycerides (MCT) per se could increase muscle and cognitive function in frail elderly subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Iteration numbers in legs open and close
Key secondary outcomes Muscle function (locomotive and respiratory) and cognitive function at baseline, during 3-mo intervention and at washout are measured.
Mid-upper-arm muscle area (AMA) is estimated by measuring triceps skin fold thickness (TSF) and mid-upper-arm circumference (AC); strength in the upper extremities is measured by a handgrip dynamometry; strength in the lower extremities is estimated by the leg extension power.
Muscle function is estimated by gait speed; swallowing ability is estimated by repetitive saliva swallowing test; strength of respiratory muscles is estimated by peak expiratory flow (PEF); ADL is estimated by Functional Independence Measure (FIM).
Cognitive function is estimated by Mini-Mental State Examination (MMSE), NM scale, and Neuropsychiatric Inventory Nursing Home Version (NPI-NH).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The first group (positive control) receives leucine-, vitamin D-enrich supplement plus MCT (LD + MCT) at dinner.
The leucine-, vitamin D-enrich supplement (Amino L40) produced by Ajinomoto Inc. (Tokyo, Japan) is purchased. One tube (100 g, 30 kcal) of Amino L40 is given at the beginning of dinner. One tube contains EAA 3 g (leucine 1.2 g, isoleucine 0.3 g, valine 0.3 g, other amino acids 1.2 g), vitamin D 20 ug (800 IU), vitamin B1 0.2 mg, vitamin B6 0.2 mg, vitamin B12 0.4 ug and water 87g.
MCT containing C8:0 75%, C10:0 25% is purchased from Nisshin OilliO Group Ltd. (Kanagawa, Japan). A 6 g of MCT (54 kcal) is mixed with steamed rice or added in a miso soup in dinner.
The intervention period is a 3 mo.
Interventions/Control_2 The second group receives MCT only.
MCT containing C8:0 75%, C10:0 25% is purchased from Nisshin OilliO Group Ltd. (Kanagawa, Japan). A 6 g of MCT (54 kcal) is mixed with steamed rice or added in a miso soup in dinner.
The intervention period is a 3 mo.
Interventions/Control_3 The third group (negative control) receives LCT only.
LCT containing C18:1 64%, C18:2 19% is purchased from Nisshin OilliO Group Ltd. (Kanagawa, Japan). A 6 g of LCT (54 kcal) is mixed with steamed rice or added in a miso soup in dinner.
The intervention period is a 3 mo.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elderly subjects in a nursing care home for the elderly volunteered to participate in a 3-mo dietary supplement intervention program.
All residents in this nursing care home need special care by other people for living. They are classified into Japanese nursing care levels with number between 1 and 5 based on assessed care needs.
Key exclusion criteria Exclusion criteria are subjects with treated with parenteral nutrition, or difficulty of swallowing, or type 1 diabetes mellitus, severe heart failure, liver, kidney, blood disease, or FBS > 200 mg/dl, or blood creatinine > 1.5 mg/dl or CRP > 2.0 mg/dl or BMI > 23 to avoid a further increase in body weight, or food allergy to supplements used in this study.
Target sample size 87

Research contact person
Name of lead principal investigator
1st name osamu
Middle name
Last name ezaki
Organization Showa Women's University
Division name Institute of Women's Health Science
Zip code 154-8533
Address 1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN
TEL 03-3411-7450
Email ezaki1952@yahoo.co.jp

Public contact
Name of contact person
1st name osamu
Middle name
Last name ezaki
Organization Showa Women's University
Division name Institute of Women's Health Science
Zip code 154-8533
Address 1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN
TEL 03-3411-7450
Homepage URL
Email ezaki1952@yahoo.co.jp

Sponsor
Institute Showa Women's University
Institute
Department

Funding Source
Organization Showa Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Human Ethics Committee of Showa Women's University
Address 1-7 Taishido, Setagaya-ku, Tokyo, 154-8533 JAPAN
Tel 03-3411-7351
Email rinri-iin@swu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 介護老人保健施設スカイ(Day Care SKY)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Related information
URL releasing protocol https://doi.org/10.1093/ajcn/nqz138
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1093/ajcn/nqz138
Number of participants that the trial has enrolled 64
Results 
Please see the following published paper:

Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are
promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin
Nutr. 2019 Jul 23. pii: nqz138. doi: 10.1093/ajcn/nqz138. [Epub ahead of print]
PubMed PMID: 31334544
Results date posted
2019 Year 07 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 07 Month 23 Day
Baseline Characteristics 
Please see the following published paper:

Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are
promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin
Nutr. 2019 Jul 23. pii: nqz138. doi: 10.1093/ajcn/nqz138. [Epub ahead of print]
PubMed PMID: 31334544
Participant flow 
Please see the following published paper:

Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are
promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin
Nutr. 2019 Jul 23. pii: nqz138. doi: 10.1093/ajcn/nqz138. [Epub ahead of print]
PubMed PMID: 31334544
Adverse events 
Please see the following published paper:

Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are
promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin
Nutr. 2019 Jul 23. pii: nqz138. doi: 10.1093/ajcn/nqz138. [Epub ahead of print]
PubMed PMID: 31334544
Outcome measures 
Please see the following published paper:

Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are
promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin
Nutr. 2019 Jul 23. pii: nqz138. doi: 10.1093/ajcn/nqz138. [Epub ahead of print]
PubMed PMID: 31334544
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2016 Year 07 Month 01 Day
Anticipated trial start date
2016 Year 08 Month 25 Day
Last follow-up date
2017 Year 02 Month 28 Day
Date of closure to data entry
2017 Year 05 Month 30 Day
Date trial data considered complete
2017 Year 08 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 23 Day
Last modified on
2019 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026751